Senior Executive, Process Engineering

Description:

The role is responsible for executing, coordinating, and improving pharmaceutical manufacturing processes to ensure quality, safety, regulatory compliance, cost efficiency, and operational performance. The role focuses on designing, optimizing, and implementing production processes, interpreting process layouts, drawings, specifications, and SOPs, and supporting process validation, scale-up, and technology transfer activities. It involves process monitoring, troubleshooting, deviation and CAPA execution, and change control management. The position contributes to stable, compliant, and efficient manufacturing operations by applying engineering standards, regulatory guidelines, performance monitoring, and continuous improvement practices across production processes.

Essential Functions:

• Execute and support process design, optimization, and implementation activities
• Monitor and analyze process parameters, KPIs, and production performance trends
• Support and execute process validation (IQ/OQ/PQ) and documentation activities
• Conduct process trials, testing, and troubleshooting across manufacturing stages
• Manage deviation, investigation, CAPA, and change control activities
• Ensure process compliance with regulatory and quality requirements
• Support process scale-up, technology transfer, and optimization initiatives
• Coordinate with cross-functional teams during routine operations and projects
• Maintain technical documentation, batch records, and validation reports
• Drive continuous improvement and lean manufacturing initiatives
• Follow safety engineering, risk assessment, and GMP practices

Additional Responsibilities:

Education:

• Bachelors Degree (BA/BS) B.Tech - Required
• Master Degree (MS/MA) M.Tech - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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